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Astex Therapeutics and Multiple Myeloma Research Consortium Announce Start of Phase II Clinical Study of AT7519 in Multiple Myeloma



8/12/2010 11:24:05 AM

Cambridge, UK, and Norwalk, Connecticut, USA, 12 August 2010. Astex Therapeutics, the UK-based biotechnology company developing targeted therapies for oncology and virology, and the Multiple Myeloma Research Consortium (MMRC) announced today the initiation of a Phase II clinical trial of the cyclin-dependent kinase (CDK) inhibitor, AT7519, to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer. The trial is designed to investigate both single agent and combination activity of AT7519 with bortezomib (Velcade®).

The MMRC’s affiliate organization, the Multiple Myeloma Research Foundation (MMRF) has supported the development of AT7519 through its Biotech Investment Award (BIA) program, which provided funding to rapidly test the pre-clinical activity of the compound in multiple myeloma, as well as move it forward into clinical trials. This clinical trial will be conducted through MMRC Member Institution sites and others in the USA.

“Continuing our relationship with Astex in the advancement of AT7519 confirms the effectiveness of our end-to-end drug development model, including identifying promising drug candidates, funding early research and injecting efficiency into the development process,” said Kathy Giusti, Founder and CEO of the MMRF and MMRC. “We collaborate with industry partners like Astex, so that promising new treatments can be brought to myeloma patients, faster.”

Dr. Noopur Raje (Massachusetts General Hospital Cancer Center, Boston, Massachusetts) is the Principal Investigator. The MMRF-supported work in Dr. Raje’s laboratory published in the April issue of Oncogene1 has demonstrated that AT7519 has significant anti-tumour activity in pre-clinical models of multiple myeloma and supports its further development in this disease.

“The cyclins are over-expressed in the majority of myeloma patients making them an attractive therapeutic target. AT7519, in addition to its potent CDK inhibitory activity works against other kinases relevant to myeloma biology distinguishing it from some of the CDK inhibitors currently in clinical trials and we are very excited to bring this to our patients,” said Noopur Raje, Director of the Center for Multiple Myeloma at Massachusetts General Hospital.

AT7519 has already been tested in two international Phase I trials in patients with solid tumours, and the dosing schedule from one of these trials has been chosen for the trial in multiple myeloma patients.

“The MMRF is the world’s number-one private funder of multiple myeloma research; we are delighted to continue the collaboration to accelerate the clinical development of our novel compound, AT7519, underlining the quality of drug candidates generated by Astex”, said Harren Jhoti, Founder and Chief Executive Officer of Astex. “The funding provided by the MMRF Biotech Investment Award, combined with the MMRC’s commitment to quality and track record of speed allows us to conduct this trial of our proprietary CDK inhibitor as a potential new treatment for patients with multiple myeloma.”

“Despite significant treatment advances, multiple myeloma remains an incurable disease, with one of the lowest five-year survival rates of any cancer. MMRC’s mission is to help bring next-generation therapeutics like AT7519 to patients as quickly as possible,” said Susan Kelley, Chief Medical Officer of the MMRC. “We are delighted to be partnered with Astex in support of the clinical development of AT7519.”

Velcade® is a registered trademark of Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

1 AT7519, A novel small molecule multi-cyclin-dependent kinase inhibitor, induces apoptosis in multiple myeloma via GSK-3ß activation and RNA polymerase II inhibition. L Santo, S Vallet, T Hideshima, D Cirstea, H Ikeda, S Pozzi, K Patel, Y Okawa, G Gorgun, G Perrone, E Calabrese, M Yule, M Squires, M Ladetto, M Boccadoro, P G Richardson, N C Munshi, K C Anderson and N Raje. Oncogene (2010), 29(16): 2325-2336.

Contact Jeremy Carmichael, PhD Director of Business Development Astex Therapeutics Ltd 436 Cambridge Science Park Milton Road, Cambridge CB4 0QA, UK Tel: +44(0)1223 226200 Fax: +44(0)1223 226201 j.carmichael@astex-therapeutics.com www.astex-therapeutics.com

Debra Venech Marketing Communications Manager Multiple Myeloma Research Foundation Tel: 203-652-0232 venechd@themmrf.org

About Multiple Myeloma Multiple myeloma is an incurable cancer of the plasma cell. The five-year relative survival rate for multiple myeloma is approximately 35%, one of the lowest of all cancers. In 2010, an estimated 20,180 adults (11,170 men and 9,010 women) in the United States will be diagnosed with multiple myeloma and an estimated 10,650 people will die from the disease.

About Astex Therapeutics Astex is a UK-based biotechnology company that discovers and develops novel small molecule therapeutics. Using its pioneering fragment-based drug discovery platform Pyramid™, Astex has built a pipeline of five molecularly-targeted oncology drugs, of which three are currently being tested in clinical trials and two are in pre-clinical development. In addition to its proprietary research programmes, Astex’s productivity in lead discovery has been endorsed through numerous partnerships with major pharmaceutical companies, including AstraZeneca, Bayer-Schering, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Johnson & Johnson. For further information on Astex please visit the Company’s website at www.astex-therapeutics.com

About the Multiple Myeloma Research Consortium (MMRC) The Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is led from MMRC offices in Norwalk, Conn., and comprises 13 member institutions: University of California, San Francisco, City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the Cancer Center at Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Mayo Clinic, Ohio State University, Mount Sinai School of Medicine, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, and Washington University. The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community. The MMRC is an affiliate organization of the Multiple Myeloma Research Foundation (MMRF), the world's leading funder of multiple myeloma research. The MMRC is widely recognized as an optimal research model to rapidly address critical challenges in drug development and to explore opportunities in the today's most promising research areas–genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank. For more information, please visit: www.themmrc.org.

About the Multiple Myeloma Research Foundation (MMRF) The Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)3 non-profit organization by twin sisters Karen Andrews and Kathy Giusti, soon after Kathy's diagnosis with multiple myeloma. The mission of the MMRF is to relentlessly pursue innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure. As the world's number-one private funder of multiple myeloma research, the MMRF has raised over $140 million since its inception to fund nearly 120 laboratories worldwide, including 40 new compounds and approaches in clinical trials and pre-clinical studies and has facilitated 25 clinical trials through its sister organization, the Multiple Myeloma Research Consortium (MMRC). As exceptional stewards of its donor’s investments, the MMRF consistently surpasses its peers in fiscal responsibility. For more information about the MMRF, please visit www.themmrf.org.


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